Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Campinas, Brazil.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01527526
First received: November 16, 2011
Last updated: June 17, 2013
Last verified: February 2012

November 16, 2011
June 17, 2013
February 2011
May 2012   (final data collection date for primary outcome measure)
insulin resistance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months
Same as current
Complete list of historical versions of study NCT01527526 on ClinicalTrials.gov Archive Site
  • weight gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study
  • eating disorder [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study
  • loss of bone mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study
  • changes in clotting factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    other arm of the study
Same as current
Not Provided
Not Provided
 
Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism
Prospective Study for Evaluation of the Insulin Resistance, Lipid Metabolism and Sub Clinical Cardiovascular Disease in Women Who Initiate the Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method With in Follow-up for Two Years

Objective:

The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users.

Method:

Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum samples for determination of lipid profile, insulin, glucose, coagulation factors, neuropeptide Y and factors related to bone mineral density.

Non-Probability Sample

Will be included women new-users DMPA, looking for the clinic's family planning FCM-UNICAMP, from primary care centers in Campinas, São Paulo, Brazil.

  • Insulin Resistance
  • Cardiovascular Disease
  • Bone Loss
  • Eating Disorders
  • Thrombosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
May 2014
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-40 years
  • new users of DMPA
  • BMI<30kg/m²

Exclusion Criteria:

  • diabetes mellitus and 2 present or fasting glucose> 100mg/dl and / or blood glucose> 140mg/dl after ingestion of 75mg of oral glucose
  • first-degree relatives with diabetes mellitus
  • period of lactation
  • hypertension, with or without treatment
  • hyper and hypothyroidism
  • chronic renal failure
  • transplant of any organ
  • women using drugs that may be related to weight gain and / or development of insulin resistance and chronic use of corticosteroids, antipsychotics, statins, and thiazide,
  • hirsutism and/or hyperandrogenism
  • polycystic Ovary Syndrome (PCOS)
  • women with acanthosis nigricans
  • women who have used depoprovera at some point in their reproductive lives,
  • women who have performed bariatric surgery
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01527526
09/2011/PC
No
Luis Bahamondes, University of Campinas, Brazil
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Luis Bahamondes, M.D. University of Campinas, Brazil
University of Campinas, Brazil
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP